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Use of a highly-sensitive rapid diagnostic test to screen for malaria in pregnancy in Indonesia

Unwin, Vera, Ahmed, Rukhsana, Noviyanti, Rintis, Puspitasari, Agatha M., Utami, Retno A. S., Trianty, Leily, Lukito, Theda, Syafruddin, Din, Poespoprodjo, Jeanne R., Santana-Morales, Maria A., terKuile, Feiko ORCID: https://orcid.org/0000-0003-3663-5617 and Adams, Emily ORCID: https://orcid.org/0000-0002-0816-2835 (2020) 'Use of a highly-sensitive rapid diagnostic test to screen for malaria in pregnancy in Indonesia'. Malaria Journal, Vol 19, Issue 28.

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Abstract

Background:
The sensitivity of rapid diagnostic tests (RDTs) for malaria is inadequate for detecting low‑density, often asymptomatic infections, such as those that can occur when screening pregnant women for malaria. The perfor‑ mance of the Alere™ Ultra‑sensitive Malaria Ag Plasmodium falciparum RDT (uRDT) was assessed retrospectively in pregnant women in Indonesia.
Methods:
The diagnostic performance of the uRDT and the CareStart™ Malaria HRP2/pLDH VOM (Plasmodium vivax, Plasmodium ovale and Plasmodium malariae) Combo RDT (csRDT) were assessed using 270 stored red blood cell pel‑ lets and plasma samples from asymptomatic pregnant women. These included 112 P. falciparum negative and 158 P. falciparum positive samples detected by a composite test (qPCR, LAMP, nPCR) as reference standard. Diagnostic indicators: sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), diagnostic odds ratio (DOR) and the level of agreement (kappa) were calculated for comparison.
Results:
Compared with the reference test, the uRDT had a sensitivity of 19.6% (95% CI 13.9–26.8) and specificity of 98.2% (93.1–99.7%). The csRDT was 22.8% (16.7–30.3) sensitive and 95.5% (89.4–98.3) specific for P. falciparum infec‑ tions. Performance of the uRDT was non‑significantly different to the csRDT (p = 0.169). RDT outcome was stratified by qPCR cycling threshold (Ct), and performance of the RDTs was found to be comparable across parasite loads.
Conclusion:
The uRDT performed similarly to the currently used csRDTs in detecting P. falciparum infections in asymptomatic pregnant women. In these settings, molecular diagnostics are currently the most sensitive for malaria.

Item Type: Article
Subjects: WA Public Health > Health Problems of Special Population Groups > WA 310 Maternal welfare
WA Public Health > Health Problems of Special Population Groups > WA 395 Health in developing countries
WC Communicable Diseases > Tropical and Parasitic Diseases > WC 750 Malaria
WC Communicable Diseases > Tropical and Parasitic Diseases > WC 765 Prevention and control
WQ Obstetrics > Pregnancy Complications > WQ 240 Pregnancy complications (General)
Faculty: Department: Biological Sciences > Department of Tropical Disease Biology
Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI): https://doi.org/10.1186/s12936-020-3110-6
Depositing User: Cathy Waldron
Date Deposited: 24 Jan 2020 09:41
Last Modified: 24 Jan 2020 09:41
URI: https://archive.lstmed.ac.uk/id/eprint/13568

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